This webinar will help you manage the risks associated with GCP non-compliance at a pivotal investigator site. The training will follow a case-study approach to help you learn how to determine investigator non-compliance and guide you in deciding whether or not to file the efficacy study data in a regulatory application.
While risk management is a sponsor multi- functional process that begins before the study site is set; there is a single sponsor decision that exposes the sponsor to regulatory consequences beyond simply filing the study data in a regulatory application. The determination of GCP compliance, or the significance of any noted investigator non-compliance, should guide the decision to file the efficacy study data in a regulatory application, or not.
This webinar will include a discussion of two real case studies with significant GCP non-compliance where sponsor regulatory, clinical, and ultimately management decisions were associated with two very different outcomes. One of these companies was the subject of a regulatory agency enforcement action and closed down. The other company successfully brought the study product through an approved NDA.
Why Should You Attend:
GCP Non-compliance at the investigator site remains the sponsor’s primary liability for the rejection of the regulatory application. Fifty percent of all FDA study related investigational site inspections incur some level of GCP noncompliance observations. Most of these GCP non-compliance observations do not result in a rejection of the sponsor regulatory application. Sponsors must be able to make this assessment.While risk management is a sponsor multi- functional process that begins before the study site is set; there is a single sponsor decision that exposes the sponsor to regulatory consequences beyond simply filing the study data in a regulatory application. The determination of GCP compliance, or the significance of any noted investigator non-compliance, should guide the decision to file the efficacy study data in a regulatory application, or not.
This webinar will include a discussion of two real case studies with significant GCP non-compliance where sponsor regulatory, clinical, and ultimately management decisions were associated with two very different outcomes. One of these companies was the subject of a regulatory agency enforcement action and closed down. The other company successfully brought the study product through an approved NDA.
Areas Covered in the Seminar:
- How to confirm and enable the CQA conclusions.
- Which of the 7 GCP compliance objectives directly compromise data integrity?
- Which of the 7 GCP compliance objectives impact acceptability of the submission regardless of the integrity of the study data?
- How the management decision process determined the outcome in these cases.
- How to identify the risk factors associated with filing this data in a regulatory submission in terms.
- of identification of the specific risks,
- of evaluation of the liability of incurring those risks,
- and of exposure to those risks.
- How to determine the cost for NOT submitting the data.
- How to assure that the perspectives of investigator, the sponsor, and the regulatory agency are all part of the final decision.
- The role of the sponsor in causing the GCP non-compliance for each of the cases.
- What sponsor risk management process applied proactively could have avoided this non-compliance?
- What functions should be represented on the core team.
- Which function makes the final file/no file decision?
- Does management really want to know the bad news?
- How the risks associated with filing the data compromised by the GCP non Compliance may vary from FDA, MHRA, EMA, and SFDA.
- If success is the best teacher- what worked and what did not work for these two companies.
Who Will Benefit:
- CQA Managers
- Clinical Research Managers
- Project Management
- Regulatory Affairs
- Risk Management
- Clinical Operations
- Site Managers and Staff
- Prinicipal Investigators
Course Provider
Stephen Schwartz,
